FDA approves Empagliflozin for reducing kidney disease progression in CKD patients
The U.S. Food and Drug Administration (FDA) has granted approval for empagliflozin 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.
This approval for isolated CKD is primarily based on the results of the EMPA-KIDNEY trial.
In the EMPA-KIDNEY trial, 6,609 adults with CKD and specific eGFR (glomerular filtration rate) and urinary albumin-to-creatinine ratio criteria were randomly assigned to receive either empagliflozin or a placebo. After a median follow-up period of 2.0 years, the trial demonstrated a significant 28% relative reduction in the primary endpoint—a composite of kidney disease progression or death from cardiovascular causes—in the empagliflozin group compared to the placebo group.
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